Pilot Study of a Mobile, Virtual Reality–Based Digital Therapeutic for Smoking Cessation: Randomized Controlled Trial
Abstract
Background Smoking cessation remains a global challenge, with traditional treatments showing limited long-term success due to low adherence and accessibility issues. Digital therapeutics, such as mobile apps and virtual reality (VR)–based interventions, could offer innovative solutions for smoking cessation treatment. NICO-THERA is a digital therapeutic program integrating cognitive behavioral therapy (CBT) and motivational enhancement therapy (MET) to address nicotine dependence. Objective This study aims to evaluate the safety and efficacy of NICO-THERA, a digital therapeutic intervention combining VR and mobile apps, for supporting smoking cessation among individuals with nicotine dependence. The primary focus was on smoking abstinence, nicotine dependence reduction, and motivation to quit smoking over a 12-week intervention period. Methods This open-label, exploratory, randomized controlled trial involved 30 participants randomly assigned to the digital therapeutic group (DTG; n=15; mean age 43.1 years; mean number of daily cigarettes: 9.5) or basic treatment group (BTG; n=15; mean age 48.7 years; mean number of daily cigarettes: 9.2). The DTG received the NICO-THERA program, involving VR sessions (relaxation training, craving coping, and refusal skills) and mobile app–based CBT and MET modules for daily therapeutic exercises. The BTG received basic care including video education and printed materials. The primary outcomes were the 7-day point prevalence abstinence (PPA)…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 30 participants or records.
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